SOP on Testing of Materials & Products

Testing (Materials & Products)
1.0 Purpose: This SOP describes the requirements for the testing of materials and products.
2.0 Scope: This SOP applies to the Quality Control Chemist.  
3.0 Responsibility: Quality Control Manager to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: 
5.01 Each lot of materials should not be allowed to use until the lot has been sampled, tested or examined, as appropriate, and released for use by the Quality Control Laboratory.
5.02 Representative samples of each shipment of each lot should be collected for testing or examination. The number of containers to be sampled, and the amount of material to be taken from each container, should be based upon statistical criteria, confidence levels and degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis and reserve sample. 
5.03 At least one specific test should be conducted to verify the identity of each component of a drug product. 
5.04 Each component should be tested for conformity with all appropriate written specifications ( pharmacopoeial or in-house) for purity, strength, and quality.
5.05 All the packaging components should be tested for conformance with appropriate written in-house specifications.
5.06 When appropriate components should be microscopically examined.Wherever applicable, the materials / products should be examined for microbiological parameters like total microbial count, E.coli, Salmonella, P. aeruginosa and S.aureus.
6.0 Reporting: Record the results in analysis report.

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